Adult: In patients who were previously treated with a course of corticosteroids but did not have a clinically significant increase in IOP: As 0.19 mg implant: Administer 1 implant in the affected eye via intravitreal inj. Not recommended to be given concurrently in both eyes. Treatment recommendations may vary between countries. Refer to the specific product guideline for further instructions on pre-treatment, administration and repeat dosing.
Intravitreal Chronic non-infectious uveitis of posterior segment of eye
Adult: As 0.18 mg implant: Administer 1 implant in the affected eye via intravitreal inj. As 0.59 mg implant: Administer 1 silicone-encased tab implant into the posterior segment of the affected eye via intravitreal inj. Refer to the specific product guideline for further instructions on pre-treatment, administration and repeat dosing.
Otic/Aural Chronic eczematous otitis externa
Adult: As 0.01% otic drops: Instil 5 drops into the affected ear(s) bid for 1-2 weeks. Child: ≥2 years As 0.01% otic drops: Same as adult dose.
Adult: As 0.0025% or 0.00625% cream and 0.00625% ointment: Apply a thin layer to the affected area(s) 2-3 times daily depending on the severity of the condition. As 0.01% or 0.025% cream, 0.025% ointment, and 0.01% topical solution: Apply a thin layer to the affected area(s) 2-4 times daily depending on the severity of the condition. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines). Child: As 0.0025%, 0.00625%, 0.01% or 0.025% cream, 0.00625% or 0.025% ointment, and 0.01% topical solution: ≥1 year Same as adult dose. Dosage recommendations and recommendations on the treatment duration and use of occlusion may vary among individual product or between countries (refer to detailed product guidelines).
Topical/Cutaneous Atopic dermatitis
Adult: As 0.01% body oil: Apply a thin layer to the affected area(s) tid. Child: For moderate to severe cases: As 0.01% body oil: ≥3 months Moisten the skin, then apply a thin layer to affected area(s) bid for up to 4 weeks.
Topical/Cutaneous Scalp psoriasis
Adult: As 0.025% gel: Initially, apply a small amount onto the scalp bid (morning and evening). Maintenance dose upon improvement: Apply once weekly or 2 times weekly. As 0.01% scalp oil: Apply a thin layer to wet or dampened scalp once daily as needed; massage it well onto the scalp and cover with a shower cap. Leave on overnight or for at least 4 hours before washing off using a regular shampoo, then rinse thoroughly.
Topical/Cutaneous Seborrhoeic dermatitis of scalp
Adult: As 0.025% gel: Initially, apply a small amount onto the scalp bid (morning and evening). Maintenance dose upon improvement: Apply once weekly or 2 times weekly.
What are the brands available for Fluocinolone acetonide in Philippines?
Topical: Untreated fungal, bacterial or viral skin lesions; acne, rosacea, anogenital pruritus, napkin eruptions, perioral dermatitis. Intravitreal: Active or suspected ocular/periocular infections, including most viral corneal or conjunctival diseases, active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; active bacterial, mycobacterial and fungal infections of the eye; pre-existing glaucoma (0.19 mg implant).
Special Precautions
Intravitreal: Patient with glaucoma, high baseline IOP, absent posterior lens capsule, or posterior capsule defect/tear; history of bacterial, mycobacterial, fungal or viral corneal and conjunctival infections. Not recommended in patients with a history of ocular herpes simplex (intravitreal). Avoid prolonged topical use, particularly on the face. Children. Pregnancy and lactation.
Adverse Reactions
Significant: HPA axis suppression or hypercortisolism (particularly in younger children or at high doses for prolonged periods); Kaposi's sarcoma (prolonged use); development of secondary infections; delayed healing or worsened concomitant skin infections; increased risk of glaucoma and posterior subscapular cataract formation; systemic effects (e.g. manifestations of Cushing's syndrome, hyperglycaemia, glycosuria); local skin reactions (e.g. allergic contact dermatitis, skin atrophy, telangiectasia, perioral dermatitis, folliculitis, hypopigmentation, miliaria, striae, acneiform eruptions) that frequently occur with occlusive dressing and/or prolonged use; topical steroid withdrawal reactions (after discontinuation of long-term use), may be manifested as severe redness which can spread beyond the initial affected area, itching, burning or stinging sensation, skin peeling, and oozing pustules. Intravitreal: Endophthalmitis, eye inflammation, increased IOP, retinal or choroidal detachment, vitreous haemorrhage or detachment, hypotony, wound dehiscence; ocular perforation, increased risk of bleb formation (after cataract surgery). Blood and lymphatic system disorders: Anaemia (intravitreal). Eye disorders: Eye pain and irritation, eye pruritus, blurred vision, dry eye, vitreous floaters, foreign body sensation, vitreous opacity, conjunctivitis, photopsia, ocular hyperaemia, reduced visual acuity, conjunctival haemorrhage. Gastrointestinal disorders: Nausea, vomiting (intravitreal). General disorders and administration site conditions: Local application site reactions (e.g. burning sensation, itching, irritation, dryness). Immune system disorders: Local hypersensitivity reactions. Infections and infestations: Influenza (intravitreal). Musculoskeletal and connective tissue disorders: Back pain, limb pain, arthralgia (intravitreal). Nervous system disorders: Headache; dizziness (intravitreal). Renal and urinary disorders: Renal failure (intravitreal). Skin and subcutaneous tissue disorders: Rash, erythema, pruritus, skin papule. Vascular disorders: Hypertension (intravitreal).
Topical/otic: Avoid contact with eyes. Topical (long-term use): Inform the doctor immediately if severe redness which can spread beyond the initial affected area, itching, burning or stinging sensation, and skin peeling occur after treatment discontinuation. Intravitreal: This drug may cause temporary blurred vision after administration, if affected, do not drive or operate machinery.
Monitoring Parameters
Topical: Monitor growth in children and HPA axis suppression (e.g. ACTH stimulation test, urinary free cortisol test), particularly during prolonged use and if applied to a large surface area or under occlusion. Assess for signs of bacterial or fungal infection. Intravitreal: Closely monitor for increased IOP and signs of endophthalmitis following inj. Evaluate for perfusion of optic nerve head immediately after inj, tonometry within 30 minutes, and biomicroscopy between 2-7 days following inj. Monitor IOP at least every 3 months thereafter. Assess the integrity of the implant periodically by visual inspection (for 0.59 mg implant).
Action
Description: Mechanism of Action: Fluocinolone acetonide is a potent corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It induces phospholipase A2 inhibitory proteins (lipocortins) and sequentially inhibits the release of arachidonic acid, thereby depressing the formation, release, and activity of endogenous chemical mediators of inflammation (e.g. kinins, histamine, liposomal enzymes, prostaglandins). Duration: Intravitreal: Approx 36 months (0.19 mg and 0.18 mg implant); approx 30 months (0.59 mg implant). Pharmacokinetics: Absorption: Topical: Absorbed percutaneously; extent of absorption may depend on the formulation, integrity of the epidermal barrier, and use of occlusive dressings. Distribution: Intravitreal: Distributed into the aqueous and vitreous humour (0.59 mg implant). Metabolism: Metabolised in the liver. Excretion: Mainly via urine; bile.
Chemical Structure
Fluocinolone acetonide Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 6215, Fluocinolone Acetonide. https://pubchem.ncbi.nlm.nih.gov/compound/Fluocinolone-Acetonide. Accessed Apr. 28, 2025.
Storage
Topical cream/ointment/solution/gel/body oil/scalp oil: Store between 20-25°C. Otic drops: Store between 15-30°C. Discard any unused portion 2 months following initial use. Intravitreal implant: Store between 15-25°C. Do not refrigerate or freeze. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines).
S01BA15 - fluocinolone acetonide ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye. S02BA08 - fluocinolone acetonide ; Belongs to the class of corticosteroids used in the treatment of inflammation of the ear. D07AC04 - fluocinolone acetonide ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
References
Brayfield A, Cadart C (eds). Fluocinolone Acetonide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/03/2025.Derma-Smoothe/FS Body Oil (Royal Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/03/2025.Derma-Smoothe/FS Scalp Oil (Royal Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/03/2025.DermOtic Oil (Royal Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/03/2025.Flac Otic Oil (Patrin Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/03/2025.Fluocinolone (Ophthalmic). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/03/2025.Fluocinolone (Otic). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/03/2025.Fluocinolone (Topical). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/03/2025.Fluocinolone Acetonide Cream and Ointment (Cosette Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/03/2025.Fluocinolone Acetonide Topical Solution 0.01% (Encube Ethicals Private Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/03/2025.Fluocinolone. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 04/03/2025.Iluvien 190 micrograms Intravitreal Implant in Applicator (Alimera Sciences Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/03/2025.Iluvien Implant (Alimera Sciences, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/03/2025.Joint Formulary Committee. Fluocinolone Acetonide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/03/2025.Retisert Implant (Bausch & Lomb Incorporated). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/03/2025.Specialised Therapeutics Limited. Iluvien 190 micrograms Intravitreal Implant in Applicator data sheet 09 June 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 04/03/2025.Supricort Cream 0.025% w/v (Glenmark Pharmaceuticals [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 04/03/2025.Synalar Cream (Reig Jofre UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/03/2025.Synalar Cream 1 in 10 Dilution (Reig Jofre UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/03/2025.Synalar Cream 1 in 4 Dilution (Reig Jofre UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/03/2025.Synalar Gel (Reig Jofre UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/03/2025.Synalar Ointment 0.025% w/w (Reig Jofre UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/03/2025.Synalar Ointment 1 in 4 Dilution (Reig Jofre UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/03/2025.Topical Corticosteroids: Information on the Risk of Topical Steroid Withdrawal Reactions. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/drug-safety-update. Accessed 04/03/2025.Topical Steroids: Introduction of New Labelling and a Reminder of the Possibility of Severe Side Effects, Including Topical Steroid Withdrawal Reactions. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/drug-safety-update. Accessed 04/03/2025.Yutiq Implant (EyePoint Pharmaceuticals US, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/03/2025.
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